Hormones manufacturing facility requirements
26 April 2024
TRS 1052 - Annex 2: WHO good manufacturing practices for excipients used in pharmaceutical products TRS 1052 - Annex 2: WHO good manufacturing practices for excipients used in pharmaceutical products
14 November 2022
TRS 1044 - Annex 5: WHO good manufacturing practices for medicinal gases TRS 1044 - Annex 5: WHO good manufacturing practices for medicinal gases
31 October 2022
TRS 1044 - Annex 2: WHO good manufacturing practices for sterile pharmaceutical products TRS 1044 - Annex 2: WHO good manufacturing practices for sterile pharmaceutical products
30 September 2022
TRS 1044 - Annex 6: WHO good practices for research and development facilities of pharmaceutical products TRS 1044 - Annex 6: WHO good practices for research and development facilities of pharmaceutical products
31 August 2022
TRS 1044 - Annex 7: WHO good manufacturing practices for investigational products TRS 1044 - Annex 7: WHO good manufacturing practices for investigational products
31 July 2022
TRS 1044 - Annex 3: IAEA/WHO guideline on good manufacturing practices for investigational TRS 1044 - Annex 3: IAEA/WHO guideline on good manufacturing practices for investigational
30 April 2022
TRS 1044 - Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing TRS 1044 - Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing
17 November 2021
TRS 1033 - Annex 3: Good manufacturing practices: water for pharmaceutical use TRS 1033 - Annex 3: Good manufacturing practices: water for pharmaceutical use
10 October 2021
TRS 1033 - Annex 4: WHO Guideline on data integrity TRS 1033 - Annex 4: WHO Guideline on data integrity
10 October 2021
TRS 1033 - Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation TRS 1033 - Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation
30 September 2020
20 April 2020
TRS 1025 - Annex 3: Production of water for injection by means other than distillation TRS 1025 - Annex 3: Production of water for injection by means other than distillation
20 April 2020
TRS 1025 - Annex 6: Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance TRS 1025 - Annex 6: Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance
30 September 2019
TRS 1019 - Annex 2: WHO good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (part 2): interpretation of guidelines TRS 1019 - Annex 2: WHO good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (part 2): interpretation of guidelines
25 January 2019
TRS 1019 - Annex 3: Good manufacturing practices: guidelines on validation TRS 1019 - Annex 3: Good manufacturing practices: guidelines on validation
10 October 2018
TRS 1010 - Annex 8: Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products TRS 1010 - Annex 8: Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products
30 September 2018
TRS 1010 - Annex 2: WHO good manufacturing practices for the manufacture of herbal medicines TRS 1010 - Annex 2: WHO good manufacturing practices for the manufacture of herbal medicines
30 September 2018
TRS 1010 - Annex 1: WHO good manufacturing practices for the manufacture of herbal medicines TRS 1010 - Annex 1: WHO good manufacturing practices for the manufacture of herbal medicines
14 April 2016
TRS 996 - Annex 3: WHO good manufacturing practices for biological products (jointly with the Expert Committee on Biological Standardization) TRS 996 - Annex 3: WHO good manufacturing practices for biological products (jointly with the Expert Committee on Biological Standardization)
31 October 2015
TRS 992 - Annex 4: General guidance on hold-time studies TRS 992 - Annex 4: General guidance on hold-time studies
1 October 2014
TRS 986 - Annex 2: WHO good manufacturing practices for pharmaceutical products: Main principles TRS 986 - Annex 2: WHO good manufacturing practices for pharmaceutical products: Main principles
25 January 2013
TRS 981 - Annex 2: WHO guidelines on quality risk management TRS 981 - Annex 2: WHO guidelines on quality risk management
30 September 2011
TRS 961 - Annex 4: WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization) TRS 961 - Annex 4: WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization)
1 October 2010
TRS 957 - Annex 2: WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances) TRS 957 - Annex 2: WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)
30 September 2010
TRS 957 - Annex 3: WHO good manufacturing practices for pharmaceutical products containing hazardous substances TRS 957 - Annex 3: WHO good manufacturing practices for pharmaceutical products containing hazardous substances
30 September 2010
TRS 957 - Annex 7: WHO guidelines for the preparation of a contract research organization master file TRS 957 - Annex 7: WHO guidelines for the preparation of a contract research organization master file
10 October 2002
TRS 902 - Annex 9: Guidelines on packaging for pharmaceutical products TRS 902 - Annex 9: Guidelines on packaging for pharmaceutical products
Frequently asked questions: WHO good manufacturing practices in pharmaceutical practice
